Sentec is a market leader of non-invasive respiratory monitoring solutions who develops,
manufactures, and markets patient-centric, cost-effective technologies and products that provide
clinicians with greater insight to quickly identify trends, rapidly and more accurately assess patient
respiratory status, and make more well-informed, timely care decisions – decisions that can improve
patient care. We aim to improve the lives of patients by advancing non-invasive patient care by
empowering clinicians with clinically superior monitoring and therapeutic technologies.
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Summary:
Responsible for registrations of Sentec products in the US and Canada, the Regulatory Affairs
Specialist acts as the local representative and contact person for the competent authorities. Will work
closely in conjunction with, and as an extension of, the Sentec regulatory compliance team based in
Switzerland.
Essential Duties and Responsibilities:

• Continuous monitoring and implementation of updated regulatory requirements and

standards relevant to Sentec products.

• Support development of the regulatory strategy to receive product clearances in conjunction

with Sentec Swiss regulatory team.

• Compilation of submission dossiers for new product approvals and changes to existing

approvals in close cooperation with internal and external stakeholders (e.g., regulatory
consultants).

• Serve as the primary local representative and contact to the FDA and Health Canada and other

competent authorities.

• Participate in regulatory inspections/audits by internal and external audit authorities and

prepare formal responses as warranted.

• Perform risk assessment of the obligation to report incidents and customer complaints in the

US and Canada; Report incidents to the authorities and support the implementation of
necessary measures internally (CAPAs) and in the market (FSCAs).

• Support partner companies (suppliers, dealers) regarding regulatory issues as needed.
• Act as regulatory representative on cross-functional project teams to develop regulatory

strategies, testing requirements, and other documentation to ensure that regulatory
submissions are prepared and approved to meet launch timelines for new and modified
products.

• Review product, supplier, and manufacturing changes as well as verification and validation

activities, for compliance with applicable regulations and procedures.

• Support Quality teams by providing guidance and serving as a resource in the development

and implementation of CAPA, internal audit and vendor/supplier audit programs..

• Review and approve of labeling documents with focus of compliance to pre-defined claims and

regulatory requirements.

• Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times

annually)